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U.S. Department of Health and Human Services

Class 1 Device Recall Infusion Pumps & Refill Kits

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 Class 1 Recall
Infusion Pumps & Refill Kits
see related information
Date Posted September 30, 2013
Recall Status1 Open
Recall Number Z-2299-2013
Recall Event ID 65821
Premarket Approval
PMA Number
P890055
Product Classification Pump, Infusion, Implanted, Programmable - Product Code LKK
Product MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.
Code Information OUS: Per recall strategy
Recalling Firm/
Manufacturer
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, Massachusetts 02767
For Additional Information Contact Codman Neuro Clinical Support
800-660-2660
Manufacturer Reason
for Recall
Drug flow rates exceeding programmed flow rates.
FDA Determined
Cause 2
TRAINING: Use Error
Action Codman & Shurtleff, Inc. sent a Medical Device Field Safety Notice letter dated August 13, 2013 to US Consignees via FedEx overnight delivery and International Consignees were notified of the recall via email. The letter identifed the affected products, potential clinical impact, and updated IFU pump filling warning. The letter informed consignees that the Instructions for Use (IFU) and product training materials had been updated by adding a warning statement about potential over infusion if air gets inside the pump reservoir and additional clarifications to reinforce the proper filling technique. Consignees are asked to complete the Field Safety Notice Acknowledgement Form and return it to your local Codman Neuro Sales Representative or fax to: 508-977-6665. Consignees are asked to contact your Codman Neuro representative if they have questions, or contact Codman Neuro Clinical Support at 1-800-660-2660. Please report any malfunction or adverse event related to this device to 1-866-491-0974, Option 2.
Quantity in Commerce 369 units
Distribution Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LKK and Applicant = ARROW INTL., INC.
PMAs with Product Code = LKK and Applicant = CODMAN
PMAs with Product Code = LKK and Applicant = CODMAN & SHURTLEFF, INC.
PMAs with Product Code = LKK and Applicant = THEREX CORP.
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